WASHINGTON -- A group of patients not generally considered potential organ donors could help ease the current shortage for transplants, but procedures first must be put in place first to ensure their proper care, according to a new report* from the Institute of Medicine (IOM).

These patients -- whose hearts have stopped beating but who have not been declared brain dead -- account for only 1 percent of all organs recovered from cadavers in the United States each year, and procedures for their care vary widely among the nation's 63 organ-procurement organizations. The report calls for a consistent national approach that ensures appropriate care for all organ donors and, at the same time, permits recovery of greater numbers of organs from non-heart-beating donors.

"If the estimates are accurate, non-heart-beating donors could represent an increase of at least 1,000 organ donors each year," said John Potts, Distinguished Jackson Professor of Clinical Medicine, director of research at Massachusetts General Hospital in Boston, and the principal investigator for the IOM study. "To ensure that these patients receive proper care, however, it is critical that all transplant organizations adopt a consistent approach that respects the wishes of patients and families."

More than 50,000 people were awaiting organs at the end of 1996, and more than 4,000 died last year before an organ became available, according to the United Network for Organ Sharing. Non-heart-beating donors -- who include patients on life support and are not yet brain dead, or those who have suffered cardiac arrest and cannot be resuscitated -- traditionally have accounted for a very small proportion of donations. Donors whose hearts are still beating are preferred because their organs are sustained by warm, oxygenated blood until the moment of removal, which increases the likelihood of successful transplant.

Because they are not set up to do so, many hospitals have problems rapidly identifying potential non-heart-beating donors. And there is no consistent policy among the institutions involved in transplantation on how to obtain family consent for withdrawing life support, for donating organs, or for using drugs that improve the condition of organs but may under some circumstances be harmful to the patient. Presently, the difference in policy and procedure among procurement organizations could raise questions about the motives and priorities of individual transplant programs, or the scientific and ethical standards of care for donor patients, the report says.

Consistent Approach Needed

In a survey of all 63 organ procurement organizations across the nation, the IOM study found that fewer than half have protocols in place for non-heart-beating donors. Of those organizations that have written procedures, all agreed that discussion of organ donation with families should take place only after the family has made an independent decision to withdraw life support, and that -- to avoid conflicts of interest -- the physician who declares death after withdrawal of life support should not be affiliated in any way with the organ procurement organization. Beyond these two points, however, protocols vary widely on such fundamentals as what constitutes death; what medical interventions to use to sustain organs while the patient is still alive; the role of organ procurement organizations in assessing and preparing donors; and the proper approach for obtaining family consent.

All organ procurement organizations should be required to have written policies and procedures before the organization could obtain or transplant organs from non-heart-beating donors, and the public should be allowed to view those protocols upon request. The report also concludes:

> Heparin and phentolamine -- two drugs used to enhance organ quality before being recovered from a patient -- may occasionally hasten death in some patients with certain medical conditions, although no specific instance in any donor has been reported. Because of this possibility, organ procurement organizations should not be guided by a blanket policy on whether or when to use these drugs. Clinical decisions should be made on an individual basis, in consultation with the donor's attending physician and family.

> It is ethically acceptable to use some medical procedures that do not hasten death, but are invasive and possibly painful, once the decision has been made by the family to donate organs and before life support is withdrawn. Such procedures include cannulation, in which doctors insert a tube into a body cavity or artery to deliver cooling fluids to the body to conserve organs. Family consent always must be obtained and local anesthesia should be used if needed.

> In patients who have experienced cardiac arrest after removal of life support, at least five minutes should elapse after circulation stops before death is pronounced and organ preparation or removal begins. This standard interval should be uniformly adopted by every organ procurement organization to ensure that death has occurred in all instances, and to eliminate the possibility that a donor could be defined as dead in one jurisdiction that recognizes a shorter interval, and not in another that recognizes a longer interval. Currently, that time period ranges from immediately after the heart stops in some facilities, to five minutes or longer in others. Additional scientific study should be undertaken to confirm that this five-minute requirement is adequate or more than adequate.

> Families of organ donors should be fully informed of all medical procedures, and be given privacy and time to adjust. They should be provided the option of attending the withdrawal of life support and the death of their loved ones. And any costs associated with donating organs should not be borne by families of donors.

This study was sponsored by the U.S. Department of Health and Human Services. The Institute of Medicine is a private, non-profit organization that provides health policy advice under a congressional charter granted to the National Academy of Sciences.

*Copies of Non-Heart-Beating Organ Transplantation:Medical and Ethical Issues in Procurement are available from the National Academy Press at the mailing address in the letterhead; tel. (202) 334-3313 or 1-800-624-6242. The cost is $22.00 (prepaid) plus shipping charges of $4.00 for the first copy and $.50 for each additional copy. Reporters may obtain a copy from the Office of News and Public Information at the letterhead address (contacts listed above).